EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome (EEGInspiration)
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|ClinicalTrials.gov Identifier: NCT02751216|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Other: EEG recording + pain protocol||Not Applicable|
Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication.
Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||January 2018|
|Experimental: spinal cord stimulation||
Other: EEG recording + pain protocol
- Functional connectivity [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]EEG recordings to measure functional connectivity in the brain
- Functioning of the descending inhibitory pathway [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water
- Visual Analogue Scale (VAS) pain diary [ Time Frame: Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion). ]
- Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics). [ Time Frame: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation). ]This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality
- Pain Catastrophizing [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]Pain catastrophizing is assess be using the 'pain catastrophizing scale'.
- Subjective sleep quality [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751216
|Brussels, Vlaams Brabant, Belgium, 1090|
|Principal Investigator:||Maarten Moens, Prof. dr.||Universitair Ziekenhuis Brussel|